9,287 results
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34ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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S-Guide Kit
FDA UDI
Shinhung MST Co., Ltd.·08806343919366·Keyless, precise, open guided surgery kit, desi...
LEICA PROVEO 8
FDA Adverse Event
Malfunction
·LEICA MICROSYSTEMS (SCHWEIZ) AG·Product code FSO·October 4, 2021
PLM A+ MEDNET FMW
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·April 9, 2015
Labeling is as follows: Product labeling: ''***Argon Medical Devices***RE-ORDER NO./REF 193248***12cc Control Syringe***ST/FR/TR/FM w/ Reservoir***This device is designed for the administraion and removal of fluids.***DISPOSABLE*SINGLE USE*DO NOT RESTERILIZE***STERILE EO***STERILIZED BY EtO***Argon Medical Devices, Inc. 1445 Flat Creek Road Athens, TX 75751 800-927-4669***'' Carton Labeling: ''***Argon Medical Devices***12cc Control Syringe***ST/FR/TR/FM W/ Reservoir***This device is designed for the administraion and removal of fluids.***REF/REORDER NO. 193248***Quantity: 25 ea.***STERILE EO***STERILIZED BY EtO***DISPOSABLE*SINGLE USE*DO NOT RESTERILIZE***Argon Medical Devices, Inc. 1445 Flat Creek Road Athens, TX 75751 800-927-4669***''
FDA Recall
Terminated
·Argon Medical Devices, Inc·Product code IZI·June 27, 2005
Product consists of a syringe used to inject fluids during an angiographic procedure for fluoroscopic imaging. Labeling is as follows: Product Label ''***Argon Medical Device***10cc Control Syringe FR/TR/FM w/ Reservoir SINGLE USE ONLY***REF/REORDER NO. 093205***This device is designed for the administration and removal of fluids***Quantity: 25ea***NON-STERILE*FURTHER PROCESSING REQUIRED***Eto (ethylene oxide) Sterilization Recommended***1445 FLAT CREEK ROAD - ATHENS, TX 75751***800-927-4669***'' Carton Label ''***Argon Medical Device***10cc Control Syringe FR/TR/FM w/ Reservoir SINGLE USE ONLY***REF/REORDER NO. 093205***This device is designed for the administration and removal of fluids***Quantity: 250ea***NON-STERILE*FURTHER PROCESSING REQUIRED***Eto (ethylene oxide) Sterilization Recommended***1445 FLAT CREEK ROAD - ATHENS, TX 75751***800-927-4669***''
FDA Recall
Terminated
·Argon Medical Devices, Inc·Product code IZI·June 27, 2005
Product consists of a syringe used to inject fluids during an angiographic procedure for fluoroscopic imaging. Labeling is as follows: Product Label ''***Argon Medical Device***REORDER NO./REF 193205***10cc Control Syringe FR/TR/FM w/ Reservoir***This device is designed for the administration and removal of fluids***DISPOSABLE***SINGLE USE ONLY***DO NOT RESTERILIZE***STERILE***EO***STERILIZED BY EtO***Sterile Unless Opened or Damaged***Argon Medical Devices, Inc. 1445 FLAT CREEK ROAD - ATHENS, TX 75751***800-927-4669***'' Carton Label ''***Argon Medical Device***10cc Control Syringe FR/TR/FM w/ Reservoir***This device is designed for the administration and removal of fluids***REF/REORDER NO. 193205***Quantity: 25ea***STERILE***EO***STERILIZED BY EtO***DISPOSABLE***SINGLE USE ONLY***DO NOT RESTERILIZE***Sterile Unless Opened or Damaged***Argon Medical Devices, Inc. 1445 FLAT CREEK ROAD - ATHENS, TX 75751***800-927-4669***''
FDA Recall
Terminated
·Argon Medical Devices, Inc·Product code IZI·June 27, 2005
MATTRESS COVER FOR MEDICAL PURPOSES
FDA Adverse Event
GRAND HEALTHCARE CO., LTD.·Product code FMW·May 28, 2014
MATTRESS COVER FOR MEDICAL PURPOSES
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code FMW·June 19, 2014
MATTRESS COVER FOR MEDICAL PURPOSES
FDA Adverse Event
UNKNOWN·Product code FMW·October 14, 2014
MATTRESS COVER FOR MEDICAL PURPOSES
FDA Adverse Event
UNKNOWN·Product code FMW·October 13, 2014
MATTRESS COVER FOR MEDICAL PURPOSES
FDA Adverse Event
UNKNOWN·Product code FMW·October 13, 2014
TEMPUR MED PRESSURE REDUCING PRODUCT
FDA Adverse Event
Malfunction
·TEMPUR MED·Product code FMW·April 26, 2012
MATTRESS NYLEX II
FDA Adverse Event
Death
·MEDLINE INDUSTRIES, INC.·Product code FMW·October 16, 2003
*
FDA Adverse Event
*·Product code FMW·November 18, 2003
MATTRESS COVER FOR MEDICAL PURPOSES
FDA Adverse Event
GRAND HEALTHCARE CO., LTD.·Product code FMW·October 21, 2014
MATTRESS COVER FOR MEDICAL PURPOSES
FDA Adverse Event
GRAND HEALTHCARE CO., LTD.·Product code FMW·October 24, 2014
SOFTFORM PREMIER
FDA Adverse Event
Injury
·INVACARE UK·Product code FMW·September 27, 2024
GLOBAL HEALTHCARE MATTRESS SHEET
FDA Adverse Event
GLOBAL HEALTHCARE·Product code FMW·November 23, 2010
WALGREENS BED PROTECTOR
FDA Adverse Event
Malfunction
·MEDLINE INDUSTRIES, LP·Product code FMW·April 21, 2026
XPRT SLEEP SURFACE
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code FMW·March 5, 2013